Head of QA - £70,000 - Amersham
Our client is look for a Head of QA to join their vibrant & ever-growing company on a permanent basis.
The Head of QA will be responsible for leading the QA function for the company, managing client and internal audits and line managing QA staff. We are looking for a team player who has the ability to proactively drive QA compliance across clinical research operational activities and software development within the company.
Key Responsibilities as a Head of QA :
* Ensuring that QA involvement is targeted to the business needs.
* Facilitating the development, planning and co-ordination of company SOPs and on-going maintenance and revisions.
* Maintaining the SOP training matrix.
* Implement and maintenance of a CAPA and Deviations process.
* Lead the Quality Review Committee reviewing quality risks and issues, following up any findings with recommended strategies for improvement.
* Provide support in the preparation and coordination of inspections by regulatory authorities.
* Facilitate external client QA audits, mentor and train other staff for audit readiness.
* Conduct internal facility and system audits across all operations. This will include visits to our US and Poland offices.
* Auditing of vendors and sub-contractors to ensure competence and suitability.
* Support formal training programmes by highlighting QA training requirements. Also act as a trainer on QA issues and regulations.
* Line-manage a small QA team in the UK and the US.
Key Skills as a Head of QA :
* A proactive, experienced Clinical Research QA professional (preferably with global experience).
* Expertise in GCP and clinical trial regulations.
* Experience in writing and developing SOPs and quality documents.
* Validation/GAMP/21CFRpart 11/SDLC required.
* Enrolled as a member of Research Quality Association (RQA).
Please apply as directed.